Study to Monitor the Safety and Reactogenicity of Fluarix™ in Korean Subjects Aged > 6 Months of Age.

NCT00750360 | Completed Phase 4 Results

• 1 other identifier: 218352/054
• Study Type: interventional
• Target: 883
• Locations: 0 countries
• Sites: N/A

Brief Summary

The present study collects data on safety and reactogenicity of the vaccine in the local target population (600 or more subjects) as per the requirement of Korean Food and Drugs Administration (KFDA).

Conditions

Influenza

Keywords

Influenza; Korea; FluarixTM

Outcome Measures

Primary Outcomes (1)

• Number of Participants Reporting Severe Unsolicited Adverse Events

  An Adverse Event is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Severe unsolicited adverse events are defined as adverse events which prevent normal, everyday activities

  During the 21-day follow-up period (Day 0 to Day 20) after vaccination

Secondary Outcomes (4)

• Number of Participants Reporting Solicited Local and General Adverse Events in Subjects Aged Less Than 72 Months.

  During the 4-day follow up (Day 0 to 3) after vaccination.

• Number of Participants Reporting Solicited Local and General Adverse Events in Subjects Aged 72 Months and Older.

  During the 4-day follow up (Day 0 to 3) after vaccination.

• Number of Participant Reporting Unsolicited Adverse Events.

  During the 21-day follow-up period (Day 0 to Day 20) after vaccination

• Number of Participants Reporting Serious Adverse Events (SAE).

  Within 1 month following vaccination

Study Arms (6)

Unprimed, > 6 to < 72 Months

EXPERIMENTAL

Subjects aged \> 6 months to \< 72 months who were previously not vaccinated against influenza (unprimed).

Biological: FluarixTM

Unprimed, ≥ 72 to < 108 Months

EXPERIMENTAL

Subjects aged ≥ 72 months to \< 108 months who were previously not vaccinated against influenza (unprimed).

Biological: FluarixTM

Primed, > 6 to < 72 Months

EXPERIMENTAL

Subjects aged \> 6 months to \< 72 months who previously received a vaccination against influenza (primed).

Biological: FluarixTM

Primed, ≥ 72 to < 108 Months

EXPERIMENTAL

Subjects aged ≥ 72 months to \< 108 months who previously received a vaccination against influenza (primed).

Biological: FluarixTM

Primed, ≥ 108 to < 216 Months

EXPERIMENTAL

Subjects aged ≥ 108 months to \< 216 months who previously received a vaccination against influenza (primed).

Biological: FluarixTM

Primed, ≥ 216 Months

EXPERIMENTAL

Subjects aged ≥ 216 months who previously received a vaccination against influenza (primed).

Biological: FluarixTM

Interventions

FluarixTM BIOLOGICAL

All subjects will receive a single dose of FluarixTM. For children less than 9 years of age who have not previously been vaccinated against influenza, a second dose will be given after an interval of at least 4 weeks (Group B).

Primed, > 6 to < 72 Months; Primed, ≥ 108 to < 216 Months; Primed, ≥ 216 Months; Primed, ≥ 72 to < 108 Months; Unprimed, > 6 to < 72 Months; Unprimed, ≥ 72 to < 108 Months

Eligibility Criteria

• Age: 6 Months+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• A male or female \> 6 months of age at the time of the first vaccination.
• Subjects who the investigator believes that they and/or their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study.
• Free of obvious health problems as established by medical history and clinical examination judged by the investigator before entering into the study.
• If the subject is female, she must be of non-childbearing potential, or, if of childbearing potential, she must be abstinent or have used adequate contraceptive precautions for 30 days prior to vaccination, have a negative pregnancy test and must agree to continue such precautions for two months after vaccination.

You may not qualify if:

• Clinical signs of acute febrile illness at the time of entry into the study.
• Any treatment with immunosuppressive drugs, including oral and parenteral corticosteroids.
• History of allergic disease or reactions likely to be exacerbated by any component of the vaccine or previous severe reaction to influenza virus vaccine.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Related Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2008
• First Posted: September 10, 2008
• Study Start: October 3, 2003
• Primary Completion: December 1, 2007
• Study Completion: December 28, 2007
• Last Updated: November 6, 2018
• Results First Posted: June 2, 2009

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will share